Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial
Baroukh M Assael, Tacjana Pressler, Diana Bilton, Michael Fayon, Rainald Fischer, Raphael Chiron, Mario LaRosa, Christiane Knoop, Noel McElvaney, Sandra A Lewis, Mark Bresnik, A Bruce Montgomery, Christopher M Oermann, AZLI Active Comparator Study Group, Frans de Baets, Kristin Desager, Lieven DuPont, Anne Malfroot, Marc Albertini, Chantal Belleguic, Christophe Delacourt, Philippe Domblides, Jean Francois Duhamel, Marcel Guillot, Gerard Lenoir, Sylvie Leroy, Jean Claude Pautard, Natascha Remus, Thomas Biedermann, Eckard Hamelmann, Hans-Eberhardt Heuer, Uwe Mellies, Jens Schreiber, Doris Staab, Jens-Oliver Steiss, Helmut Teschler, Hubert Wirtz, Gerard Canny, Charles Gallagher, Peter Greally, Mary Herzig, Sergio Bernasconi, Carla Colombo, Rolando Gagliardini, Vincenzina Lucidi, Francesca Pardo, Giovanna Pisi, Serena Quattrucci, Valeria Raia, Harry Heijerman, Johannes Hendriks, Adelina Amorim, Celeste Barreto, Carmen Antelo, Jose Villa Asensi, Gloria Garcia Hernandez, Luis Maiz, Francisco Peres-Frias, Annette Boehler, Alexander Moeller, Mary Carroll, Steven Conway, Stuart Elborn, Charles Haworth, Ian Ketchell, Christopher Taylor, Martin Walshaw, Frank Accurso, Steven Boas, Aaron Chidekel, Rubin Cohen, Paul Comber, Cori Daines, Robert Fink, David Geller, Gavin Graff, Denis Hadjiliadis, Jeffrey Hoag, Theodore Liou, Craig Nakamura, Edward Naureckas, David Nichols, Bruce Nickerson, Peggy Radford, Santiago Reyes, Dion Roberts, Mark Rolfe, Howard Schmidt, Pedro Sepulveda, Terry Spencer, Arvey Stone, Bruce Trapnell, Pierre Vauthy, Isabel Virella-Lowell, Johannes Eder, Watraud Eder, Katalin Kovacs, Udo Langenhorst, Elke Dewachter, Valerie Dufresne, Michel Dumonceaux, Monique Lequesne, Alain Michils, Pascal Van Bleyenbergh, Sabine Van Daele, Marianne Skov, Laurence Bassinet, Michele Berlioz, Graziella Brinchault, Francoise Ceccato, Frederique Chedevergne, Francois Counil, Benoit Desrues, Severine Gaillot, Isabelle Halphen, Vincent Boisserie Lacroix, Muriel Laurans, Stephanie Mechain-Bui, Lahouari Meziane, Thierry Perez, Alice Picard, Cinthia Rames, Bernard Romeo, Isabelle Sermet, Stephanie Vrielynck, Benoît Wallaert, Cordula Conrad-Kabbe, Norbert Grammann, Jorg Grobe-Onnebrink, Andrea Guttler, Andrea Jobst, Swante Klahr, Cordula Koerner-Rettberg, Sabine Matena, Susanne Nahrig, Hans Christoph Runge, Carsten Schwarz, Wolfgang Sextro, Albrecht Tacke, Kathrin Christina Weber, Diane Wieczorek, Monika Wolf, Peter Barry, Sanjay Chotirmall, Basil Elnazir, Cedric Gunaratnam, Edina Moylett, Trevor Nicolson, Federico Alghisi, Giuseppe Cimino, Natalia Cirilli, Marco Cipolli, Laura Claut, Diana Costantini, Annarita Costantino, Luisa De Cristofaro, Fabiola De Gregorio, Violetta Di Pierantonio, Valeria Di Stefano, Nadia Faelli, Francesco Longo, Lucia Spicuzza, Gabriella Traverso, Maria Candida Tripodi, Patrizia Troiani, Giovanna Vitaliti, Geert Jan Wesseling, Pilar Azeved, Joao Bento, José Cavaco, Luisa Pereira, Maria Isabel Gonzalez Alvarez, Pilar Caro Auvilena, Isabel Barrio, Maria Castro Codesal, Lucrecia Suarez Cortina, Marta Ruiz de Valbuena, Adelaida Lamas Ferreiro, Adolfo Sequeiros Gonzalez, Carmen Martinez, Maria Teresa Martinez, Estela Perez-Ruiz, Antonio Salcedo Posadas, Elena Urgelles, Klaus Haemmarle, Markus Hoefer, Demet Inci, Renate Spinas, Ina Aldag, Helen Barker, Gary Connett, Jane Davies, Christine Etherington, Andres Floto, Ben Green, Khin Ma Gyi, Mark Ledson, Anand Palamarthy, Felicity Perrin, Jacqueline Rendall, Dennis Wat, James Acton, Gabriel Aljadeff, Lisa Allwein, Raouf Amin, Bruce Barnett, Sandy Bartosi, Michael Biggin, Debra Boyer, Mark Brown, Terry Byars, Holly Carveth, Eduardo Cepeda-Davila, Barbara Chatfield, Michael Daines, Ruth DeVoogd, Karim Djekidel, Carolyn Donovan, Henry Dorkin, Lorrie Duan, Dawn Ericson, Monica Federico, Peter Fornos, Fadel Fuiz, James Goodwin, Gerald Gong, Roni Grad, Tarik Haddad, Anas Hadeh, Robert Heinle, Laura Herpel, Peter Hiatt, David Hicks, Douglas Kyle Hogarth, Douglas Holsclaw, Angelica Honsberg, Ashley Jones, Marion Jones, Diane Kitch, Lucille Lester, Susan Lester, Jeffrey Lewis, Floyd Livingston, Thomas Martin, Fernando Martinez, Martin Martinez, Margo Moore, Gary Mueller, Angala Narasimhan, Imre Noth, Adrian O'Hagan, Gary Onady, Raj Padman, Reynold Panettieri, Kathleen Peeke, Terri Phillips, Diane Rhodes, Jonathan Rosen, Frederick Royce, Milene Saavedra, Scott Sagel, Connie St Clair, Gregory Sawicki, Scott Schroeder, Edward S Schulman, Michael Schwartz, Amrapali Shah, Michael Sherman, Thomas C Smith, Patrick Sobande, James Stark, Antine Stenbit, Mary Strek, Alumet Uluer, Robert Vender, William Walsh, Ronald Williams, Elizabeth Woods, James Woodward, Jamie Wooldridge, Nozomi Yagi, Robert Young, Anchalee Yuengsrigul, Baroukh M Assael, Tacjana Pressler, Diana Bilton, Michael Fayon, Rainald Fischer, Raphael Chiron, Mario LaRosa, Christiane Knoop, Noel McElvaney, Sandra A Lewis, Mark Bresnik, A Bruce Montgomery, Christopher M Oermann, AZLI Active Comparator Study Group, Frans de Baets, Kristin Desager, Lieven DuPont, Anne Malfroot, Marc Albertini, Chantal Belleguic, Christophe Delacourt, Philippe Domblides, Jean Francois Duhamel, Marcel Guillot, Gerard Lenoir, Sylvie Leroy, Jean Claude Pautard, Natascha Remus, Thomas Biedermann, Eckard Hamelmann, Hans-Eberhardt Heuer, Uwe Mellies, Jens Schreiber, Doris Staab, Jens-Oliver Steiss, Helmut Teschler, Hubert Wirtz, Gerard Canny, Charles Gallagher, Peter Greally, Mary Herzig, Sergio Bernasconi, Carla Colombo, Rolando Gagliardini, Vincenzina Lucidi, Francesca Pardo, Giovanna Pisi, Serena Quattrucci, Valeria Raia, Harry Heijerman, Johannes Hendriks, Adelina Amorim, Celeste Barreto, Carmen Antelo, Jose Villa Asensi, Gloria Garcia Hernandez, Luis Maiz, Francisco Peres-Frias, Annette Boehler, Alexander Moeller, Mary Carroll, Steven Conway, Stuart Elborn, Charles Haworth, Ian Ketchell, Christopher Taylor, Martin Walshaw, Frank Accurso, Steven Boas, Aaron Chidekel, Rubin Cohen, Paul Comber, Cori Daines, Robert Fink, David Geller, Gavin Graff, Denis Hadjiliadis, Jeffrey Hoag, Theodore Liou, Craig Nakamura, Edward Naureckas, David Nichols, Bruce Nickerson, Peggy Radford, Santiago Reyes, Dion Roberts, Mark Rolfe, Howard Schmidt, Pedro Sepulveda, Terry Spencer, Arvey Stone, Bruce Trapnell, Pierre Vauthy, Isabel Virella-Lowell, Johannes Eder, Watraud Eder, Katalin Kovacs, Udo Langenhorst, Elke Dewachter, Valerie Dufresne, Michel Dumonceaux, Monique Lequesne, Alain Michils, Pascal Van Bleyenbergh, Sabine Van Daele, Marianne Skov, Laurence Bassinet, Michele Berlioz, Graziella Brinchault, Francoise Ceccato, Frederique Chedevergne, Francois Counil, Benoit Desrues, Severine Gaillot, Isabelle Halphen, Vincent Boisserie Lacroix, Muriel Laurans, Stephanie Mechain-Bui, Lahouari Meziane, Thierry Perez, Alice Picard, Cinthia Rames, Bernard Romeo, Isabelle Sermet, Stephanie Vrielynck, Benoît Wallaert, Cordula Conrad-Kabbe, Norbert Grammann, Jorg Grobe-Onnebrink, Andrea Guttler, Andrea Jobst, Swante Klahr, Cordula Koerner-Rettberg, Sabine Matena, Susanne Nahrig, Hans Christoph Runge, Carsten Schwarz, Wolfgang Sextro, Albrecht Tacke, Kathrin Christina Weber, Diane Wieczorek, Monika Wolf, Peter Barry, Sanjay Chotirmall, Basil Elnazir, Cedric Gunaratnam, Edina Moylett, Trevor Nicolson, Federico Alghisi, Giuseppe Cimino, Natalia Cirilli, Marco Cipolli, Laura Claut, Diana Costantini, Annarita Costantino, Luisa De Cristofaro, Fabiola De Gregorio, Violetta Di Pierantonio, Valeria Di Stefano, Nadia Faelli, Francesco Longo, Lucia Spicuzza, Gabriella Traverso, Maria Candida Tripodi, Patrizia Troiani, Giovanna Vitaliti, Geert Jan Wesseling, Pilar Azeved, Joao Bento, José Cavaco, Luisa Pereira, Maria Isabel Gonzalez Alvarez, Pilar Caro Auvilena, Isabel Barrio, Maria Castro Codesal, Lucrecia Suarez Cortina, Marta Ruiz de Valbuena, Adelaida Lamas Ferreiro, Adolfo Sequeiros Gonzalez, Carmen Martinez, Maria Teresa Martinez, Estela Perez-Ruiz, Antonio Salcedo Posadas, Elena Urgelles, Klaus Haemmarle, Markus Hoefer, Demet Inci, Renate Spinas, Ina Aldag, Helen Barker, Gary Connett, Jane Davies, Christine Etherington, Andres Floto, Ben Green, Khin Ma Gyi, Mark Ledson, Anand Palamarthy, Felicity Perrin, Jacqueline Rendall, Dennis Wat, James Acton, Gabriel Aljadeff, Lisa Allwein, Raouf Amin, Bruce Barnett, Sandy Bartosi, Michael Biggin, Debra Boyer, Mark Brown, Terry Byars, Holly Carveth, Eduardo Cepeda-Davila, Barbara Chatfield, Michael Daines, Ruth DeVoogd, Karim Djekidel, Carolyn Donovan, Henry Dorkin, Lorrie Duan, Dawn Ericson, Monica Federico, Peter Fornos, Fadel Fuiz, James Goodwin, Gerald Gong, Roni Grad, Tarik Haddad, Anas Hadeh, Robert Heinle, Laura Herpel, Peter Hiatt, David Hicks, Douglas Kyle Hogarth, Douglas Holsclaw, Angelica Honsberg, Ashley Jones, Marion Jones, Diane Kitch, Lucille Lester, Susan Lester, Jeffrey Lewis, Floyd Livingston, Thomas Martin, Fernando Martinez, Martin Martinez, Margo Moore, Gary Mueller, Angala Narasimhan, Imre Noth, Adrian O'Hagan, Gary Onady, Raj Padman, Reynold Panettieri, Kathleen Peeke, Terri Phillips, Diane Rhodes, Jonathan Rosen, Frederick Royce, Milene Saavedra, Scott Sagel, Connie St Clair, Gregory Sawicki, Scott Schroeder, Edward S Schulman, Michael Schwartz, Amrapali Shah, Michael Sherman, Thomas C Smith, Patrick Sobande, James Stark, Antine Stenbit, Mary Strek, Alumet Uluer, Robert Vender, William Walsh, Ronald Williams, Elizabeth Woods, James Woodward, Jamie Wooldridge, Nozomi Yagi, Robert Young, Anchalee Yuengsrigul
Abstract
Background: Open-label, parallel-group, international trial comparing aztreonam for inhalation solution (AZLI) and tobramycin nebulizer solution (TNS) for cystic fibrosis patients with airway Pseudomonas aeruginosa.
Methods: 273 patients (≥ 6 years); randomized to three 28-day courses (AZLI 75 mg [three-times/day] or TNS 300 mg [twice/day]); 28 off-days separated each course.
Results: 268 patients were treated (AZLI/TNS: 136/132). Mean baseline FEV1 was 52% predicted. Mean relative changes after 1 course (AZLI: 8.35%; TNS: 0.55%; p<0.001) and mean actual changes across 3 courses (AZLI: 2.05%; TNS: -0.66%; p=0.002) indicated AZLI statistical superiority vs. TNS. AZLI-treated patients had fewer respiratory hospitalizations (p=0.044) and respiratory events requiring additional antipseudomonal antibiotics (p=0.004); both treatments were well tolerated. 133 patients received 1 to 3 courses of AZLI treatment in the open-label extension-period (28-day courses separated by 28 days off-treatment); lung function improvements were comparable regardless of whether patients had received TNS or AZLI in the preceding comparative period.
Conclusions: AZLI demonstrated statistical superiority in lung function and a reduction in acute pulmonary exacerbations compared to TNS over 3 treatment courses (ClinicalTrials.gov: NCT00757237).
Copyright © 2012. Published by Elsevier B.V.
Source: PubMed